Parallel-importation is the importation from an EU Member State or a country within the EEA of a medicinal product which is therapeutically equivalent to a product already authorised in Ireland, by an importer who is someone other than the importer appointed by the marketing authorisation holder of the product on the Irish market.
The imported product may then be parallel-distributed in Ireland provided that the importer obtains an authorisation to market the product. An authorisation for a parallel-distributed product is identified by the letters 'PPA' in front of the authorisation number.
Further information on the licensing of parallel-imported products is available in the IMB Guide to Parallel Imports - Human Medicines. Specific applications forms are available for each type of application (new application/renewal/variation) and are available in the Publications section of the IMB website.
The IMB is not in a position to assess or comment on trademark or copyright issues relating to parallel importation. Further information on these issues can be found in the European Commission communication COM(2003) 839, available on the European Commission website.
Please note that the parallel-import of medicinal products authorised by the European Commission should be notified to the EMA. For more information, please consult the EMA website, www.ema.europa.eu
The IMB also operates a Dual-Pack Import Registration scheme. This applies to the parallel-import of a product which is identical in all respects to the product on the Irish market, and which is packaged in dual-market, identical packaging carrying the marketing authorisation numbers in both the source country and in Ireland. For parallel-imports which meet these criteria, a simplified registration process may be appropriate.
For more information, please consult the IMB Guide to Parallel Imports - Human Medicines.